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Completed

NCT Number: NCT02419612

A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Cheb, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Subjects must be willing and able to give signed and dated written informed consent
  • Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
  • Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
  • Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
  • Males and females, aged ≥18 years old at time of screening visit
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
  • WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug

Exclusion criteria

  • Clinical diagnosis of type I diabetes
  • History of diabetic ketoacidosis
  • Cardiovascular/vascular diseases within 3 months of the enrollment
  • Renal disease
  • Hepatic diseases
  • History of, or currently, acute or chronic pancreatitis
  • Hematological and oncological disease/conditions
  • Patients who have contraindications to therapy being studied
  • Patients on weight loss program(s)
  • Replacement or chronic systemic corticosteroid therapy

Treatment and study plan

Saxagliptin

Drug

Dapagliflozin

Drug

Glimepiride

Drug

Placebo

Other

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52

    Time frame: Baseline and Week 52

    To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

Secondary outcomes

  1. Change From Baseline in Total Body Weight at Week 52

    Time frame: Baseline and Week 52

    To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

  2. Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52

    Time frame: At Week 52

    Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.

  3. Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

    Time frame: Baseline and Week 52

    To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

  4. Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period

    Time frame: Up to Week 52

    Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period.

  5. Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

    Time frame: Up to Week 156

    Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period.

  6. Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156

    Time frame: At Week 156

    Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.

  7. Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

    Time frame: Up to Week 156

    Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Apr 17, 2015
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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